U.S. patent application number 11/035993 was filed with the patent office on 2006-07-20 for methods and apparatus for transmitting force to an end effector over an elongate member.
This patent application is currently assigned to USGI Medical Inc.. Invention is credited to Richard C. Ewers, Tracy D. Maahs, Ruey-Feng Peh, Vahid Saadat.
Application Number | 20060161185 11/035993 |
Document ID | / |
Family ID | 36684967 |
Filed Date | 2006-07-20 |
United States Patent
Application |
20060161185 |
Kind Code |
A1 |
Saadat; Vahid ; et
al. |
July 20, 2006 |
Methods and apparatus for transmitting force to an end effector
over an elongate member
Abstract
Apparatus and methods for conveying or transmitting force or
energy to a medical end effector coupled to a flexible or rigid
shaft are described herein. One variation of such apparatus may be
used to manipulate tissue and create a tissue fold and may
generally comprise an elongate tubular member having an end
effector disposed thereon. The end effector may comprise a tissue
engagement member adapted to engage tissue, a first stabilizing
member and a second stabilizing member positioned at the tubular
member distal end, and a launch tube adapted to pivot about the
first stabilizing member. Elements of the end effector may be
actuable via various force transmission elements and/or mechanisms.
Such force transmission elements preferably are integrated into
and/or are actuable via a handle. The force transmission mechanisms
may be utilized to actuate and/or transmit force to alternative
medical end effectors coupled to flexible or rigid shafts.
Inventors: |
Saadat; Vahid; (Saratoga,
CA) ; Ewers; Richard C.; (Fullerton, CA) ;
Peh; Ruey-Feng; (Singapore, SG) ; Maahs; Tracy
D.; (Rancho Santa Margarita, CA) |
Correspondence
Address: |
LEVINE BAGADE LLP
2483 EAST BAYSHORE ROAD, SUITE 100
PALO ALTO
CA
94303
US
|
Assignee: |
USGI Medical Inc.
San Clemente
CA
|
Family ID: |
36684967 |
Appl. No.: |
11/035993 |
Filed: |
January 14, 2005 |
Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/00535
20130101; A61B 2017/00827 20130101; A61B 2017/00349 20130101; A61B
2017/06052 20130101; A61B 2017/0488 20130101; A61B 2017/06076
20130101; A61B 2017/00867 20130101; A61B 17/0487 20130101; A61B
2017/00398 20130101; A61B 2017/00553 20130101; A61B 17/29 20130101;
A61B 2017/0417 20130101; A61B 2017/0496 20130101; A61B 2017/2927
20130101; A61B 17/0469 20130101; A61B 2017/0409 20130101; A61B
2017/0464 20130101; A61B 2017/00371 20130101; A61B 17/00234
20130101; A61B 2017/06028 20130101; A61B 2017/0419 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. Apparatus for conveying force or energy to a medical end
effector, the apparatus comprising: an elongate member having a
proximal end and a distal end, and a length therebetween, the
medical end effector positioned at the distal end of the elongate
member; and a transmission mechanism configured to transfer force
or energy between the proximal end of the elongate member and the
medical end effector, wherein the transmission mechanism is
configured to alter the direction or form of the force or energy as
it is transferred between the proximal end of the elongate member
and the medical end effector, and wherein the medical end effector
is configured to fold tissue.
2. The apparatus of claim 1, wherein the transmission mechanism is
configured to alter translational force or energy into rotational
force or energy.
3. The apparatus of claim 1, wherein the transmission mechanism
configured to alter rotational force or energy into translational
force or energy.
4. The apparatus of claim 1, wherein the transmission mechanism
configured to alter hydraulic force or energy into mechanical force
or energy.
5. The apparatus of claim 1, wherein the transmission mechanism
comprises a lead screw.
6. The apparatus of claim 1, wherein the transmission mechanism
comprises a column of ball-bearings.
7. The apparatus of claim 1, wherein the medical end effector
comprises a tissue acquisition member.
8. The apparatus of claim 1, wherein the medical end effector
comprises a tissue engagement member.
9. The apparatus of claim 1, wherein the medical end effector
comprises a tissue grasper.
10. The apparatus of claim 1, wherein the medical end effector
comprises a tissue securement element for securing folded
tissue.
11. The apparatus of claim 1, wherein the medical end effector
comprises a crimping element.
12. The apparatus of claim 1, wherein the medical end effector
comprises a tissue manipulation assembly having extension members
for folding tissue therebetween.
13. The apparatus of claim 1, wherein the medical end effector
comprises a linkage.
14. The apparatus of claim 1, wherein the medical end effector
comprises a gear.
15. The apparatus of claim 1, wherein the medical end effector
comprises a turbine.
16. The apparatus of claim 1, wherein the elongate member is
flexible, and wherein the apparatus is configured for endoluminal
placement of the end effector within a patient.
17. The apparatus of claim 1, wherein the apparatus is configured
for laparoscopic placement of the end effector within a
patient.
18. A method for performing a medical procedure with a medical end
effector disposed at a distal end of an elongate member, the method
comprising: advancing the medical end effector into a patient;
transmitting force or energy to the medical end effector from a
proximal region of the elongate member disposed outside the
patient; altering the force or energy as it is transmitted to the
medical end effector, and performing the medical procedure with the
end effector via the altered force or energy, wherein performing
the medical procedure comprises folding tissue.
19. The method of claim 18, wherein advancing the medical end
effector into a patient further comprises endoluminally advancing
the end effector into the patient.
20. The method of claim 18, wherein advancing the medical end
effector into a patient further comprises laparoscopically
advancing the end effector into the patient.
21. The method of claim 18, wherein altering the force or energy
further comprises altering the direction or form of the force or
energy.
22. The method of claim 18, wherein altering the force or energy
comprises the altering the force or energy from translational to
rotational force or energy.
23. The method of claim 18, wherein altering the force or energy
comprises the altering the force or energy from rotational to
translational force or energy.
24. The method of claim 18, wherein altering the force or energy
comprises the altering the force or energy from hydraulic to
mechanical force or energy.
25. The method of claim 18 wherein performing the medical procedure
further comprises securing the folded tissue.
Description
BACKGROUND OF THE INVENTION
[0001] Field of the Invention
[0002] The present invention relates to methods and apparatus for
conveying or transmitting force to a medical end effector over a
flexible or rigid member. The methods and apparatus may, for
example, be used to form and secure gastrointestinal ("GI") tissue
folds, e.g., to reduce the effective cross-sectional area of a
gastrointestinal lumen or otherwise treat a region of
gastrointestinal tissue.
[0003] Morbid obesity is a serious medical condition pervasive in
the United States and other countries. Its complications include
hypertension, diabetes, coronary artery disease, stroke, congestive
heart failure, multiple orthopedic problems and pulmonary
insufficiency with markedly decreased life expectancy.
[0004] A number of surgical techniques have been developed to treat
morbid obesity, e.g., bypassing an absorptive surface of the small
intestine, or reducing the stomach size. However, many conventional
surgical procedures may present numerous life-threatening
post-operative complications, and may cause atypical diarrhea,
electrolytic imbalance, unpredictable weight loss and reflux of
nutritious chyme proximal to the site of the anastomosis.
[0005] Furthermore, the sutures or staples that are often used in
these surgical procedures typically require extensive training by
the clinician to achieve competent use, and may concentrate
significant force over a small surface area of the tissue, thereby
potentially causing the suture or staple to tear through the
tissue. Many of the surgical procedures require regions of tissue
within the body to be approximated towards one another and reliably
secured. The gastrointestinal lumen includes four tissue layers,
wherein the mucosa layer is the inner-most tissue layer followed by
connective tissue, the muscularis layer and the serosa layer.
[0006] One problem with conventional gastrointestinal reduction
systems is that the anchors (or staples) should engage at least the
muscularis tissue layer in order to provide a proper foundation. In
other words, the mucosa and connective tissue layers typically are
not strong enough to sustain the tensile loads imposed by normal
movement of the stomach wall during ingestion and processing of
food. In particular, these layers tend to stretch elastically
rather than firmly hold the anchors (or staples) in position, and
accordingly, the more rigid muscularis and/or serosa layer should
ideally be engaged. This problem of capturing the muscularis or
serosa layers becomes particularly acute where it is desired to
place an anchor or other apparatus transesophageally rather than
intra-operatively, since care must be taken in piercing the tough
stomach wall not to inadvertently puncture adjacent tissue or
organs.
[0007] One conventional method for securing anchors within a body
lumen to the tissue is to utilize sewing devices to suture the
stomach wall into folds. This procedure typically involves
advancing a sewing instrument through the working channel of an
endoscope and into the stomach and against the stomach wall tissue.
The contacted tissue is then typically drawn into the sewing
instrument where one or more sutures or tags are implanted to hold
the suctioned tissue in a folded condition typically known as a
plication. Another method involves manually creating sutures for
securing the plication.
[0008] One of the problems associated with these types of
procedures is the time and number of intubations needed to perform
the various procedures endoscopically. Another problem is the time
required to complete a plication from the surrounding tissue with
the body lumen. In the period of time that a patient is
anesthetized, procedures such as for the treatment of morbid
obesity or for GERD must be performed to completion. Accordingly,
the placement and securement of the tissue plication should ideally
be relatively quick and performed with a maximum level of
confidence.
[0009] Another problem with conventional methods involves ensuring
that the staple, knotted suture, or clip is secured tightly against
the tissue and that the newly created plication will not relax
under any slack which may be created by slipping staples, knots, or
clips. Other conventional tissue securement devices such as suture
anchors, twist ties, crimps, etc. are also often used to prevent
sutures from slipping through tissue.
[0010] Many of these types of devices are typically large and
unsuitable for low-profile delivery through the body, e.g.,
transesophageally. This may be due to difficulties in applying,
deploying and/or deforming such devices with low-profile end
effectors disposed at significant distances from a medical
practitioner, i.e., due to an inability to convey adequate force to
the devices and/or end effectors along desired vectors across the
significant distances. These difficulties may be exacerbated when
the end effectors are coupled to the distal ends of flexible
shafts. It is expected that enhanced capabilities for transmitting
or conveying force to a medical device end effector coupled to a
flexible or rigid shaft would facilitate myriad minimally invasive
procedures, such as endoluminal treatment for morbid obesity.
BRIEF SUMMARY OF THE INVENTION
[0011] In creating tissue plications, a tissue plication tool
having a distal tip may be advanced (transorally, transgastrically,
etc.) into the stomach. The tissue may be engaged or grasped, and
the engaged tissue may be moved to a proximal position relative to
the tip of the device, thereby providing a substantially uniform
plication of predetermined size. In order to first create the
plication within a body lumen of a patient, various methods and
devices may be implemented. The anchoring and securement devices
may be delivered and positioned via an endoscopic or laparoscopic
endoluminal apparatus that engages a tissue wall of the
gastrointestinal lumen, creates one or more tissue folds, and
disposes one or more of the anchors through the tissue fold(s). The
tissue anchor(s) may be disposed through the muscularis and/or
serosa layers of the gastrointestinal lumen.
[0012] One variation of an apparatus that may be used to manipulate
tissue and create a tissue fold may generally comprise an elongate
tubular member having a proximal end, a distal end, and a length
therebetween; and an end effector. The end effector may comprise a
tissue engagement member in one variation, which is slidably
disposed through the tubular member, having a distal end adapted to
engage tissue, an upper or first stabilizing member and a lower or
second stabilizing member positioned at the tubular member distal
end and adapted to stabilize tissue therebetween, and a launch tube
adapted to pivot about the first stabilizing member. The first and
second stabilizing members preferably are adapted to be angled
relative to a longitudinal axis of the elongate tubular member.
[0013] The end effector may be manipulated and articulated through
various mechanisms. One such assembly that integrates each of the
functions into a singular unit may comprise a handle assembly,
which is connected via the tubular member to elements of the end
effector. Such a handle assembly optionally may be configured to
separate from the tubular member, thus allowing for reusability of
the handle. An articulation control may also be positioned on the
handle to provide for selective articulation of the extension
members and/or other elements of the end effector.
[0014] One particular variation of the handle assembly may have a
handle enclosure formed in a tapered configuration, which is
generally symmetrically-shaped about a longitudinal axis extending
from the distal end to the proximal end of the handle assembly. The
symmetric feature may allow for the handle to be easily manipulated
by the user regardless of the orientation of the handle enclosure
during a tissue manipulation procedure.
[0015] To articulate the multiple features desirably integrated
into a singular handle assembly, e.g., advancement and/or
deployment of the launch tube, anchor assembly, needle assembly,
articulation of the extension members and end effector, etc., a
specially configured locking mechanism may be located within the
handle enclosure. Such a locking mechanism may generally be
comprised of an outer sleeve disposed about inner sleeve where the
outer sleeve has a diameter, which allows for its unhindered
rotational and longitudinal movement relative to the inner sleeve.
A needle deployment locking control may extend radially from the
outer sleeve and protrude externally from the enclosure for
manipulation by the user. The outer sleeve may also define a needle
assembly travel path along its length. The travel path may define
the path through which the needle assembly may traverse in order to
be deployed.
[0016] The needle assembly may define one or more guides protruding
from the surface of the assembly, which may be configured to
traverse within the travel path. The inner sleeve may also define
guides protruding from the surface of the inner sleeve for
traversal within grooves defined in the handle enclosure. Moreover,
the outer sleeve is preferably disposed rotatably about the inner
sleeve such that the outer sleeve and inner sleeve are configured
to selectively interlock with one another in a corresponding manner
when the locking control is manipulated into specified
positions.
[0017] Elements of the end effector may be actuable via various
force transmission elements described hereinafter. Such force
transmission elements optionally may be integrated into and/or
actuable via the handle. It should be understood that the force
transmission elements optionally may be utilized to actuate and/or
convey force to alternative medical end effectors coupled to
flexible or rigid shafts.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1A shows a side view of one variation of a tissue
plication apparatus which may be used to create tissue plications
and to deliver cinching or locking anchors into the tissue.
[0019] FIGS. 1B and 1C show detail side and perspective views,
respectively, of the tissue approximation assembly of the device of
FIG. 1A.
[0020] FIGS. 2A to 2D show side views, partially in section, of the
tissue plication apparatus of FIG. 1 creating a tissue
plication.
[0021] FIG. 3A shows a cross-sectional side view of an anchor
delivery assembly delivering a basket-type anchor into or through a
tissue fold.
[0022] FIG. 3B shows a cross-sectional side view of multiple tissue
folds which may be approximated towards one another and basket
anchors as being deliverable through one or both tissue folds.
[0023] FIGS. 4A and 4B show side views of one variation of the
tissue manipulation assembly having cam-actuated extension
members.
[0024] FIGS. 4C and 4D show detail views of the cam-actuation for
the assembly of FIGS. 4A and 4B.
[0025] FIGS. 5A and 5B show side views of another variation of
extension members which are biased towards one another.
[0026] FIGS. 6A and 6B show side views of another variation of
extension members which are actuated via a linkage assembly.
[0027] FIGS. 7A to 7C show side views of another variation of
extension members which are actuatable via one or more hinged arms
interconnecting the extension members.
[0028] FIGS. 8A and 8B show side views of another variation where
one or more extension members are biased away from one another.
[0029] FIGS. 9A and 9B show side views of another variation where
one or more extension members are configured to be passively
biased.
[0030] FIGS. 10A and 10B show side views of another variation of
extension members which are actuatable via a translatable
sleeve.
[0031] FIG. 11 shows a side view of a tissue manipulation assembly
with a lower extension member having a longer length than the upper
extension member.
[0032] FIG. 12 shows a side view of another variation where one or
both extension members may have tips atraumatic to tissue.
[0033] FIGS. 13A and 13B views of a variation of lower extension
members which may be configured to be actuatable.
[0034] FIG. 13C show a top view of a lower extension member which
may be configured into a "C" shape.
[0035] FIGS. 14A and 14B show perspective and top views of a lower
extension member having one or more energize-able wires disposed
thereon for tissue ablation.
[0036] FIGS. 15A to 15E show side views, partially in section, of
the apparatus of FIG. 14 creating and securing a tissue plication,
while initiating a wound healing response.
[0037] FIGS. 16A to 16C show side views of a tissue manipulation
assembly which may be configured to articulate into an angle
relative to the tubular body.
[0038] FIGS. 17A to 17C show partial side views of variations of a
handle for controlling and articulating the tissue manipulation
assembly.
[0039] FIGS. 18A to 18C show top, side, and cross-sectional views,
respectively, of another variation of a handle having a
multi-position locking and needle assembly advancement system.
[0040] FIG. 18D shows an assembly view of the handle of FIG. 18A
connected to the tissue manipulation assembly via a rigid or
flexible tubular body or shaft.
[0041] FIGS. 19A and 19B show perspective and cross-sectional
views, respectively, of another variation of a handle having a
reversible configuration.
[0042] FIGS. 20A and 20B show partial cross-sectional side and
detail views, respectively, of another variation of a handle having
a pivotable articulation control.
[0043] FIG. 21A shows a side view of the handle of FIG. 20A having
the multi-position locking and needle assembly advancement
system.
[0044] FIGS. 21B to 21D show end views of the handle of FIG. 21A
and the various positions of the multi-position locking and needle
assembly advancement system.
[0045] FIG. 22A shows a perspective view of one variation of the
multi-position locking and needle assembly advancement system.
[0046] FIGS. 22B to 22E show illustrative side views of the system
of FIG. 22A configured in various locking and advancement
positions.
[0047] FIG. 23 illustrates a side view of a needle deployment
assembly which may be loaded or advanced into an approximation
assembly.
[0048] FIG. 24A shows a side view of one variation of a needle
deployment assembly.
[0049] FIG. 24B shows an exploded assembly of FIG. 24A in which the
tubular sheath is removed to reveal the anchor assembly and
elongate pusher element.
[0050] FIGS. 25A and 25B show partial cross-sectional side views of
a shuttle element advanced within the needle assembly housing.
[0051] FIGS. 26A and 26B illustrate one variation of deploying the
anchors using the needle assembly.
[0052] FIG. 26C illustrates a partial cross-sectional view of one
variation of the needle and anchor assemblies positioned within the
launch tube.
[0053] FIG. 27 is a schematic view of apparatus comprising a
medical end effector coupled to a handle via an elongate tubular
body.
[0054] FIG. 28 is a side view, partially in section, of a
transmission element or mechanism for transmitting force or energy
to a medical end effector.
[0055] FIGS. 29A and 29B are side views, partially in section, of a
transmission mechanism that transmits and converts rotational
motion into translation motion via a lead screw.
[0056] FIGS. 30A and 30B are side views, partially in section, of a
transmission mechanism that converts rotational motion into
translational motion and actuates a linkage to initiate a more
complex motion that actuates a tissue grasper.
[0057] FIGS. 31A and 31B are side views, partially in section, of
an alternative embodiment of the apparatus of FIG. 30 comprising a
tissue manipulation assembly having extension members.
[0058] FIGS. 32A and 32B are side views, partially in section, of a
transmission mechanism that facilitates coordinated reorientation
or pivoting of extension members of a tissue manipulation
assembly.
[0059] FIGS. 33A and 33B are side views, partially in section, of a
transmission mechanism that converts hydraulic energy into
mechanical energy.
[0060] FIGS. 34A and 34B are side views, partially in section, of
another embodiment of a hydraulically-actuated medical end
effector.
[0061] FIGS. 35A and 35B are, respectively, a side-sectional view
and a cross-sectional view, of another hydraulically-actuated end
effector.
[0062] FIGS. 36A and 36B are side views, partially in section, of
yet another hydraulically-actuated end effector.
[0063] FIGS. 37A and 37B are side views, partially in section, of a
transmission mechanism that converts electrical energy into
rotational and translational mechanical energy.
[0064] FIGS. 38A and 38B are side views, partially in section, of a
transmission mechanism that converts electrical energy into a
complex mechanical motion.
[0065] FIGS. 39A and 39B are side views, partially in section, of a
motor-actuated linkage.
[0066] FIGS. 40A and 40B are side views, partially in section, of a
transmission mechanism comprising a column of ball-bearings.
[0067] FIGS. 41A and 41B are, respectively, a side-sectional view
and a side-sectional detail view, of a crimping or grasping end
effector actuated via a ball-bearing column transmission
mechanism.
[0068] FIGS. 42A and 42B are side views, partially in section, of a
transmission mechanism utilizing geometric constraints.
[0069] FIGS. 43A-43D are side views, partially in section,
illustrating apparatus and a method for deforming a crimp with a
linkage assembly actuated via a lead screw transmission
mechanism.
[0070] FIGS. 44A and 44B are side views, partially in section, of
an alternative embodiment of the apparatus and method of FIG.
43.
[0071] FIGS. 45A and 45B are side views, partially in section, of a
linkage actuated via translational motion.
[0072] FIG. 46 is a schematic view of a generic transmission
mechanism for transmitting force or energy to a medical end
effector.
DETAILED DESCRIPTION OF THE INVENTION
[0073] In creating tissue plications, a tissue plication tool
having a distal tip may be advanced (transorally, transgastrically,
etc.) into the stomach. The tissue may be engaged or grasped and
the engaged tissue may be moved to a proximal position relative to
the tip of the device, thereby providing a substantially uniform
plication of predetermined size. Examples of creating and forming
tissue plications may be seen in further detail in U.S. patent
application Ser. No. 10/735,030 filed Dec. 12, 2003, which is
incorporated herein by reference in its entirety.
[0074] In order to first create the plication within a body lumen
of a patient, various methods and devices may be implemented. The
anchoring and securement devices may be delivered and positioned
via an endoscopic apparatus that engages a tissue wall of the
gastrointestinal lumen, creates one or more tissue folds, and
disposes one or more of the anchors through the tissue fold(s). The
tissue anchor(s) may be disposed through the muscularis and/or
serosa layers of the gastrointestinal lumen.
[0075] Generally, in creating a plication through which a tissue
anchor may be disposed within or through, a distal tip of a tissue
plication apparatus may engage or grasp the tissue and move the
engaged tissue to a proximal position relative to the tip of the
device, thereby providing a substantially uniform plication of
predetermined size.
[0076] Formation of a tissue fold may be accomplished using at
least two tissue contact areas that are separated by a linear or
curvilinear distance, wherein the separation distance between the
tissue contact points affects the length and/or depth of the fold.
In operation, a tissue grabbing assembly end effector engages or
grasps the tissue wall in its normal state (i.e., non-folded and
substantially flat), thus providing a first tissue contact area.
The first tissue contact area then is moved to a position proximal
of a second tissue contact area to form the tissue fold. A tissue
anchor assembly then may be extended across the tissue fold at the
second tissue contact area. Optionally, a third tissue contact
point may be established such that, upon formation of the tissue
fold, the second and third tissue contact areas are disposed on
opposing sides of the tissue fold, thereby providing backside
stabilization during extension of the anchor assembly across the
tissue fold from the second tissue contact area.
[0077] The first tissue contact area may be utilized to engage and
then stretch or rotate the tissue wall over the second tissue
contact area to form the tissue fold. The tissue fold then may be
articulated to a position where a portion of the tissue fold
overlies the second tissue contact area at an orientation that is
substantially normal to the tissue fold. A tissue anchor then may
be delivered across the tissue fold at or near the second tissue
contact area. An apparatus which is particularly suited to deliver
the anchoring and securement devices described herein may be seen
in further detail in co-pending U.S. patent application Ser. No.
10/840,950 filed May 7, 2004, which is incorporated herein by
reference in its entirety.
[0078] An illustrative side view of a tissue plication assembly 10
which may be utilized with the tissue anchors described herein is
shown in FIG. 1A. The plication assembly 10 generally comprises a
catheter or tubular body 12 which may be configured to be
sufficiently flexible for advancement into a body lumen, e.g.,
transorally, percutaneously, laparoscopically, etc. Tubular body 12
may be configured to be torqueable through various methods, e.g.,
utilizing a braided tubular construction, such that when handle 16
is manipulated and rotated by a practitioner from outside the body,
the torquing force is transmitted along body 12 such that the
distal end of body 12 is rotated in a corresponding manner.
[0079] Tissue manipulation assembly or end effector 14 is located
at the distal end of tubular body 12 and is generally used to
contact and form the tissue plication, as mentioned above. FIG. 1B
shows an illustrative detail side view and FIG. 1C shows a
perspective view of tissue manipulation assembly/end effector 14
which shows launch tube 18 extending from the distal end of body 12
and in-between the arms of upper extension member or bail 20.
Launch tube 18 may define launch tube opening 24 and may be
pivotally connected near or at its distal end via hinge or pivot 22
to the distal end of upper bail 20. Lower extension member or bail
26 may similarly extend from the distal end of body 12 in a
longitudinal direction substantially parallel to upper bail 20.
Upper bail 20 and lower bail 26 need not be completely parallel so
long as an open space between upper bail 20 and lower bail 26 is
sufficiently large enough to accommodate the drawing of several
layers of tissue between the two members.
[0080] Several variations of the tissue plication assembly 10 and
some of the various apparatus used therewith are disclosed in
further detail herein below as well as in U.S. patent application
Ser. No. 10/954,666 filed Sep. 29, 2004, which is incorporated
herein by reference in its entirety.
[0081] Upper bail 20 is shown in the figure as an open looped
member and lower bail 26 is shown as a solid member; however, this
is intended to be merely illustrative and either or both members
may be configured as looped or solid members. Tissue acquisition
member 28 may be an elongate member, e.g., a wire, hypotube, etc.,
which terminates at a tissue grasper or engager 30, in this example
a helically-shaped member, configured to be reversibly rotatable
for advancement into the tissue for the purpose of grasping or
acquiring a region of tissue to be formed into a plication. Tissue
acquisition member 28 may extend distally from handle 16 through
body 12 and distally between upper bail 20 and lower bail 26.
Acquisition member 28 may also be translatable and rotatable within
body 12 such that tissue engager 30 is able to translate
longitudinally between upper bail 20 and lower bail 26. To support
the longitudinal and rotational movement of acquisition member 28,
an optional guide or linear bearing 32 may be connected to upper 20
or lower bail 26 to freely slide thereon. Guide 32 may also be
slidably connected to acquisition member 28, such that guide 32
supports the longitudinal motion of acquisition member 28.
[0082] An example of a tissue plication procedure is seen in FIGS.
2A to 2D for delivering and placing a tissue anchor and is
disclosed in further detail in co-pending U.S. patent application
Ser. No. 10/840,950 filed May 7, 2004, which has been incorporated
by reference above. Tissue manipulation assembly 14, as seen in
FIG. 2A, may be advanced into a body lumen such as the stomach and
positioned adjacent to a region of tissue wall 40 to be plicated.
During advancement, launch tube 18 may be configured in a delivery
profile such that tube 18 is disposed within or between the arms of
upper bail 20 to present a relatively small profile.
[0083] Once tissue manipulation assembly 14 has been desirably
positioned relative to tissue wall 40, tissue grasper or engager 30
may be advanced distally such that tissue grasper or engager 30
comes into contact with tissue wall 40 at acquisition location or
point 42. As tissue grasper or engager 30 is distally advanced
relative to body 12, guide 32, if utilized, may slide distally
along with tissue grasper or engager 30 to aid in stabilizing the
grasper. If a helically-shaped tissue grasper or engager 30 is
utilized, as illustrated in FIG. 2B, it may be rotated from its
proximal end at handle 16 and advanced distally until the tissue at
point 42 has been firmly engaged by tissue grasper or engager 30.
This may require advancement of tissue grasper or engager 30
through the mucosal layer and at least into or through the
underlying muscularis layer and possibly into or through the serosa
layer.
[0084] The grasped tissue may then be pulled proximally between
upper 20 and lower bails 26 via tissue grasper or engager 30 such
that the acquired tissue is drawn into a tissue fold 44, as seen in
FIG. 2C. As tissue grasper or engager 30 is withdrawn proximally
relative to body 12, guide 32 may also slide proximally to aid in
stabilizing the device especially when drawing the tissue fold
44.
[0085] Once the tissue fold 44 has been formed, launch tube 18 may
be advanced from its proximal end at handle 16 such that a portion
46 of launch tube 18, which extends distally from body 12, is
forced to rotate at hinge or pivot 22 and reconfigure itself such
that portion 46 forms a curved or arcuate shape that positions
launch tube opening 24 perpendicularly relative to a longitudinal
axis of body 12 and/or bail members 20, 26. Launch tube 18, or at
least portion 46 of launch tube 18, is preferably fabricated from a
highly flexible material or it may be fabricated, e.g., from
Nitinol tubing material which is adapted to flex, e.g., via
circumferential slots, to permit bending. Alternatively, assembly
14 may be configured such that launch tube 18 is reconfigured
simultaneously with the proximal withdrawal of tissue grasper or
engager 30 and acquired tissue 44.
[0086] As discussed above, the tissue wall of a body lumen, such as
the stomach, typically comprises an inner mucosal layer, connective
tissue, the muscularis layer and the serosa layer. To obtain a
durable purchase, e.g., in performing a stomach reduction
procedure, the staples or anchors used to achieve reduction of the
body lumen are preferably engaged at least through or at the
muscularis tissue layer, and more preferably, the serosa layer.
Advantageously, stretching of tissue fold 44 between bail members
20, 26 permits an anchor to be ejected through both the muscularis
and serosa layers, thus enabling durable gastrointestinal tissue
approximation.
[0087] As shown in FIG. 2D, once launch tube opening 24 has been
desirably positioned relative to the tissue fold 44, needle
assembly 48 may be advanced through launch tube 18 via manipulation
from its proximal end at handle 16 to pierce preferably through a
dual serosa layer through tissue fold 44. Needle assembly 48 is
preferably a hollow tubular needle through which one or several
tissue anchors may be delivered through and ejected from in
securing the tissue fold 44, as further described below.
[0088] Because needle assembly 48 penetrates the tissue wall twice,
it exits within the body lumen, thus reducing the potential for
injury to surrounding organs. A detail cross-sectional view is
shown in FIG. 3A of anchor delivery assembly 50 in proximity to
tissue fold F. In this example, tissue fold F may comprise a
plication of tissue created using the apparatus described herein or
any other tool configured to create such a tissue plication. Tissue
fold F 30 may be disposed within a gastrointestinal lumen, such as
the stomach, where tissue wall W may define the outer or serosal
layer of the stomach. Anchor delivery assembly may generally
comprise launch tube 18 and needle assembly 48 slidingly disposed
within launch tube lumen 52. Needle assembly 48 is generally
comprised of needle 54, which is preferably a hollow needle having
a tapered or sharpened distal end to facilitate its travel into
and/or through the tissue. Other parts of the assembly, such as
upper and lower bail members 20, 26, respectively, and tissue
acquisition member 28 have been omitted from these figures only for
clarity.
[0089] Once launch tube 18 has been desirably positioned with
respect to tissue fold F, needle 54 may be urged or pushed into or
through tissue fold F via delivery push tube or catheter 64 from
its proximal end preferably located within handle 16. Delivery push
tube or catheter 64 may comprise an elongate flexible tubular
member to which needle 54 is connected or attached via joint 62.
Alternatively, needle 54 and delivery push tube 64 may be
integrally formed from a singular tubular member. Needle 54 may
define needle lumen 56 through which basket anchor assembly 66,
i.e., distal anchor 58 and/or proximal anchor 60 may be situated
during deployment and positioning of the assembly. A single suture
or flexible element 76 (or multiple suture elements) may connect
proximal anchor 60 and distal anchor 58 to one another. For
instance, element 76 may comprise various materials such as
monofilament, multifilament, or any other conventional suture
material, elastic or elastomeric materials, e.g., rubber,
biocompatible metal wire, such as Nitinol, stainless steel,
Titanium, etc.
[0090] The proximal end of suture 76 may pass slidingly through
proximal anchor 60 to terminate in a suture loop. The proximal end
of suture 76 may terminate proximally of the apparatus 10 within
control handle 16, proximally of control handle 16, or at some
point distally of control handle 16. In this variation, a suture
loop may be provided to allow for a grasping or hooking tool to
temporarily hold the suture loop for facilitating the cinching of
proximal 60 and distal 58 anchors towards one another for retaining
a configuration of tissue fold F, as described in further detail in
U.S. patent application Ser. No. 10/840,950, which has been
incorporated by reference above.
[0091] After needle assembly 48 has been pushed distally out
through launch tube opening 24 and penetrated into and/or through
tissue fold F, as shown in FIG. 3A, anchor pushrod or member 78 may
be actuated also via its proximal end to eject distal anchor 58.
Once distal anchor 58 has been ejected distally of tissue fold F,
needle 54 may be retracted back through tissue fold F by either
retracting needle 54 back within launch tube lumen 18 or by
withdrawing the entire anchor delivery assembly 50 proximally
relative to tissue fold F.
[0092] Once needle 54 has been retracted, proximal anchor 60 may
then be ejected from launch tube 18 on a proximal side of tissue
fold F. With both anchors 58, 60 disposed externally of launch tube
18 and suture 76 connecting the two, proximal anchor 60 may be
urged into contact against tissue fold F, as shown in FIG. 3B. As
proximal anchor 60 is urged against tissue fold F, proximal anchor
60 or a portion of suture 76 may be configured to provide any
number of directionally translatable locking mechanisms which
provide for movement of an anchor along suture 76 in a first
direction and preferably locks, inhibits, or prevents the reverse
movement of the anchor back along suture 76. In other alternatives,
the anchors may simply be delivered through various elongate hollow
tubular members, e.g., a catheter, trocars, etc.
[0093] The basket anchors may comprise various configurations
suitable for implantation within a body lumen. Basket anchors are
preferably reconfigurable from a low profile delivery configuration
to a radially expanded deployment configuration in which a number
of struts, arms, or mesh elements may radially extend once released
from launch tube 18 or needle 54. Materials having shape memory or
superelastic characteristics or which are biased to reconfigure
when unconstrained are preferably used, e.g., spring stainless
steels, Ni--Ti alloys such as Nitinol, etc. In FIGS. 3A and 3B,
each of the basket anchor 58, 60 is illustrated as having a number
of reconfigurable struts or arm members 72 extending between distal
collar 68 and proximal collar 70; however, this is intended only to
be illustrative and suitable basket anchors are not intended to be
limited to baskets only having struts or arms. Examples of suitable
anchors are further described in detail in U.S. patent application
Ser. No. 10/612,170, which has already been incorporated herein
above.
[0094] FIG. 3B shows distal basket anchor 58 delivered through
tissue fold F via needle 54 and launch tube 18. As above, the other
parts of the plication assembly, such as upper and lower bail
members 20, 26, respectively, and tissue acquisition member 28 have
been omitted from these figures only for clarity.
[0095] FIG. 3B shows one variation where a single fold F may be
secured between proximal anchor 60 and distal anchor 58'. As seen,
basket anchor 58' has been urged or ejected from needle 54 and is
shown in its radially expanded profile for placement against the
tissue surface. In such a case, a terminal end of suture 76 may be
anchored within the distal collar of anchor 58' and routed through
tissue fold F and through, or at least partially through, proximal
anchor 60, where suture 76 may be cinched or locked proximally of,
within, or at proximal anchor 60 via any number of cinching
mechanisms. Proximal anchor 60 is also shown in a radially expanded
profile contacting tissue fold F along tissue contact region 74.
Locking or cinching of suture 76 proximally of proximal anchor 60
enables the adequate securement of tissue fold F.
[0096] Various examples of cinching devices and methods which may
be utilized with the tools and devices herein are described in
further detail in U.S. patent application Ser. No. 10/840,950 filed
May 7, 2004, which has been incorporated herein above.
[0097] If additional tissue folds are plicated for securement,
distal basket anchor 58 may be disposed distally of at least one
additional tissue fold F', as shown in FIG. 3B, while proximal
anchor 60 may be disposed proximally of tissue fold F. As above,
suture 76 may be similarly affixed within distal anchor 58 and
routed through proximal anchor 60, where suture 76 may be cinched
or locked via proximal anchor 60, as necessary. If tissue folds F
and F' are to be positioned into apposition with one another,
distal basket anchor 58 and proximal anchor 60 may be approximated
towards one another. As described above, proximal anchor 60 is
preferably configured to allow suture 76 to pass freely
therethrough during the anchor approximation. However, proximal
anchor 60 is also preferably configured to prevent or inhibit the
reverse translation of suture 76 through proximal anchor 60 by
enabling uni-directional travel of anchor 60 over suture 76. This
cinching feature thereby allows for the automated locking of
anchors 58, 60 relative to one another during anchor
approximation.
[0098] With respect to the anchor assemblies described herein, the
types of anchors shown and described are intended to be
illustrative and are not limited to the variations shown. For
instance, several of the tissue anchor variations are shown as
"T"-type anchors while other variations are shown as reconfigurable
"basket"-type anchors, which may generally comprise a number of
configurable struts or legs extending between at least two collars
or support members. Other variations of these or other types of
anchors are also contemplated for use in an anchor assembly.
Moreover, a single type of anchor may be used exclusively in an
anchor assembly; alternatively, a combination of different anchor
types may be used in an anchor assembly. Furthermore, the different
types of cinching or locking mechanisms are not intended to be
limited to any of the particular variations shown and described but
may be utilized in any of the combinations or varying types of
anchors as practicable.
[0099] The upper and/or lower extension members or bails may also
be configured into a variety of embodiments, which may be utilized
in any number of combinations with any of the tissue acquisition
member variations as practicable. Although the upper and lower
extension members or bails may be maintained rigidly relative to
one another, the upper and/or lower extension members may be
alternatively configured to articulate from a closed to an open
configuration or conversely from an open to a closed configuration
for facilitating manipulation or stabilization of tissue drawn
between the bail members.
[0100] In operation, once the selected region of tissue has been
acquired by the tissue grasper 30, the obtained tissue may be
proximally withdrawn between the bail members, which may act as
stabilizers for the tissue. To accommodate large portions of
grasped tissue between the bail members, one or both bail members
may be articulated or urged to open apart from one another to allow
the tissue to enter and become positioned between the bail members.
One or both bail members may then be articulated or urged to clamp
or squeeze the tissue fold between the bail members to facilitate
stabilization of the tissue fold for tissue manipulation and/or
anchor deployment and/or any other procedure to be undertaken.
[0101] One such articulatable extension assembly may be seen in the
side views of FIGS. 4A and 4B. Other features such as the launch
tube and tubular body have been omitted merely for the sake of
clarity for the following illustrations. As seen in FIG. 4A, upper
extension member 182 and lower extension member 184 of active
extension assembly 180 may be configured to have an open or spread
configuration relative to one another when guide or linear bearing
186 is positioned distally along upper extension member 182. Linear
bearing 186 may be configured to slide freely along upper extension
member 182 when urged by acquisition member 28 distally or
proximally. Rather than having linear bearing 186 slide along upper
extension member 182, it may be configured alternatively to slide
along lower extension member 184.
[0102] With tissue grasper 30 and acquisition member 28 distally
protruding from extension members 182, 184, as shown in FIG. 4A,
the desired region of tissue may be acquired by rotating tissue
grasper 30 into the tissue. Once tissue has been acquired by tissue
grasper 30, the tissue may be pulled between the opened extension
members 182, 184 by proximally withdrawing tissue grasper 30 and
linear bearing 186 may be forced proximally over upper extension
member 182, as shown in the detail view of FIG. 4C. One or more
projections or pistons 188 may protrude proximally from linear
bearing 186 such that one or more of these projections 188 comes
into contact with actuation lever or member 192, as shown in FIG.
4D, which may be located proximally of extension members 182, 184
and connected in a pivoting relationship with lower extension
member 184 about pivot 190. As linear bearing 186 is urged
proximally and projection 188 presses against actuation lever 192,
lower extension member 184 may be rotated about pivot 190 such that
lower extension member 184 is urged towards upper extension member
182 to securely clamp onto and retain any tissue positioned between
the extension members 182, 184.
[0103] Another articulatable extension assembly may be seen in
assembly 200 in the side views of FIGS. 5A and 5B. In this
variation, upper extension member 202 may project distally opposite
lower extension member 204 which may be biased to close towards
upper extension member 202. When tissue grasper 30 is advanced to
engage tissue, as shown in FIG. 5A, linear bearing 206 may be urged
distally along upper extension member 202 via acquisition member 28
such that lower extension member 204 is forced or wedged away from
upper extension member 202. Once the tissue is engaged and
withdrawn proximally, linear bearing 206 may be pulled proximally
while sliding along lower member 204 and allowing lower member 204
to spring back towards upper member 202 and over any tissue
positioned therebetween, as shown in FIG. 5B.
[0104] Another articulatable extension assembly is shown in the
side views of extension assembly 210 of FIGS. 6A and 6B. In this
variation, upper extension member 212 and/or lower extension member
214 may be connected to linkage assembly 218 located proximally of
the extension members 212, 214. Linkage assembly 218 may be
manipulated via any number of control mechanisms such as control
wires to urge extension members 212, 214 between open and closed
configurations. Alternatively, linkage assembly 218 may be
configured to open or close upon the proximal or distal advancement
of linear bearing 216 relative to linkage assembly.
[0105] FIGS. 7A to 7C show side views of another variation in
extension assembly 220 where upper and lower extension members 222,
224 are articulatable between open and closed configurations via a
pivoting arm or member 234 interconnecting the two. In this
example, a first end of pivoting arm 234 may be in a pivoting
connection at pivot 228 with linear bearing 226, which may slide
translationally along upper member 222. A second end of pivoting
arm 234 may also be in a pivoting connection with lower extension
member 224 at pivot 230, which may remain fixed to lower member
224. Acquisition member 28 may also be in a third pivoting
connection with pivoting arm 234 at pivot 232, which may also be
configured to allow for the linear translation of acquisition
member therethrough.
[0106] In operation, when acquisition member 28 and tissue grasper
30 is advanced distally, as shown in FIG. 7A, both upper and lower
extension members 222, 224 are in a closed configuration with
linear bearing 226 being advanced distally along upper extension
member 222. As tissue grasper 30 is withdrawn proximally between
extension members 222, 224, pivoting arm 234 may be pivoted about
fixed pivot 230 on lower member 224 while upper member 222 is urged
into an open configuration as linear bearing 226 is urged
proximally over upper member 222, as shown in FIG. 7B. This
expanded or open configuration allows for the positioning of large
portions of tissue to be drawn between the extension members 222,
224 for stabilization. FIG. 7C shows tissue grasper 30 as having
been further withdrawn and linear bearing 226 urged proximally such
that upper member 222 is urged back into a closed configuration
relative to lower member 224. The closing of extension members 222,
224 allows for the members to further clamp upon any tissue
therebetween for further stabilization of the tissue.
[0107] FIGS. 8A and 8B show another alternative in active extension
assembly 240. In this variation, upper extension member 242 may be
biased to extend away from lower extension member 244. As shown in
FIG. 8A, upper extension member 242 may remain in an open
configuration relative to lower member 244 for receiving tissue
therebetween. In this variation, biased upper member 242 may be
urged into a closed configuration by pivoting the launch tube 18
about pivot 246, which may be located along upper member 242. As
launch tube 18 is pivoted into an anchor deployment configuration,
the pivoting action may urge upper member 242 towards lower member
244 to clamp upon any tissue therebetween.
[0108] FIGS. 9A and 9B show yet another alternative in assembly 250
where upper extension member 252 and/or lower extension member 254
may be passively urged into an open configuration. In this example,
lower extension member 254 is shown as being flexed from a relaxed
configuration in FIG. 9A to a flexed configuration in FIG. 9B. As
linear bearing 256 is withdrawn proximally, any tissue engaged to
tissue grasper 30 may urge lower extension member 254 from its
normal position 258 to its flexed and opened position. Accordingly,
lower extension member 254 and/or upper extension member 252 may be
made from a relatively flexible plastic or metallic material, e.g.,
Nitinol, spring stainless steel, etc. When tissue is removed from
between the extension members 252, 254, lower extension member 254
may return to its normal configuration 258.
[0109] FIGS. 10A and 10B show side views of another assembly 260 in
which upper and/or lower extension members 262, 264 may be biased
or configured to flex away from one another, as shown in FIG. 10A.
Once linear bearing 266 and tissue grasper 30 has been retracted,
an outer sleeve 268 slidingly disposed over tubular body 12 may be
pushed distally such that sleeve 268 is slid over at least a
proximal portion of extension members 262, 264 such that they are
urged towards one another into a closed configuration onto tissue
which may be present therebetween, as shown in FIG. 10B.
[0110] Aside from features such as articulation of the extension
members, the extension members themselves may be modified. For
instance, FIG. 11 shows a side view of extension assembly 270 where
lower extension member 274 may be extended in length relative to
upper extension member 272. The length of lower extension member
274 may be varied depending upon the desired result. Alternatively,
upper extension member 272 may be shortened relative to lower
extension member 274. The lengthening of lower extension member 274
may be utilized to present a more stable platform for tissue
approximated between the extension members 262, 264.
[0111] Another alternative for modifying the extension members is
seen in the side view of FIG. 12 in extension assembly 280. In this
example, one or both extension members 282, 284 may be configured
to have atraumatic blunted ends 286 which may be further configured
to be flexible to allow tissue to slide over the ends. Moreover,
atraumatic ends 286 may be configured in a variety of ways provided
that an atraumatic surface or feature is presented to the
tissue.
[0112] In addition to atraumatic features, the lower extension
member of the tissue manipulation assembly may be varied as well.
For example, as the needle assembly and tissue anchors are deployed
from the launch tube, typically from the upper extension member, it
is preferable to have sufficient clearance with respect to the
lower extension member so that unhindered deployment is
facilitated. One method for ensuring unhindered deployment is via a
lower extension member having a split opening defined near or at
its distal end, as shown in the perspective view of tissue
manipulation assembly 290 in FIG. 13A. Such a split may allow for
any deployed anchors or suture an opening through which to be
released from assembly 290.
[0113] Additionally, the jaws that define the opening may be
articulatable as well relative to lower extension member 294. As
shown in the bottom view of FIG. 13B, articulatable lower extension
assembly 292 may have one or both jaw members 296, 298
articulatable via pivots 300, 302, respectively, relative to lower
extension member 294 such that one or both jaw members 296, 298 are
able to be moved between a closed configuration, as shown in FIG.
13A, and an open configuration, as shown in FIG. 13B. This
variation in assembly 290 may allow for any needle or anchor
assemblies to easily clear lower extension member 294.
[0114] Another variation of lower extension member 304 is shown in
the bottom view of FIG. 13C. In this variation, an enclosing jaw
member 306 may extend from lower extension member 304 such that an
opening 308 along either side of extension member 304 is created.
Such an opening 308 may create a "C"-shaped lower extension member
304 which may facilitate needle and anchor deployment from the
tissue manipulation assembly.
[0115] Another variation of a tissue manipulation assembly 310 may
be seen in the illustrative partial perspective view of FIG. 14A.
In addition to articulation or release features, one or both
extension members may be utilized to selectively ablate regions of
tissue. Assembly 310 for instance may have a tissue ablation
assembly 312 integrated into the lower extension member 320. Such a
tissue ablation assembly 312, as seen in the top view of FIG. 14B,
may incorporate one or more wires or electrically conductive
elements 318 upon lower extension member 320 to create a tissue
ablation region. The lower extension member 320 may be fabricated
from a non-conductive material upon which wires 318 may be
integrated. Alternatively, the entire lower member 320 may be
electrically conductive with regions selectively insulated leaving
non-insulated areas to create ablation regions 318. The wires or
regions 318 may be electrically connected via wires 314 to power
source 316, which may provide various forms of energy for tissue
ablation, e.g., radio-frequency, microwave, etc.
[0116] One example for use of the ablative tissue manipulation
assembly may be seen in FIGS. 15A to 15E where tissue approximation
assembly 330 may be seen with tissue manipulation assembly 14
advanced through an optional shape-lockable overtube 332. Ablation
region 318 is integrated into the lower extension member 320 of the
tissue manipulation assembly, as above. Alternatively, region 318
may, for example, comprise an abrasive surface disposed on lower
extension member 320. Alternatively, the lower extension member 320
may comprise an ablation electrode for injuring mucosal tissue.
[0117] As seen in FIG. 15B, when tissue wall 40 is folded between
the extension members of assembly 14, target mucosal tissue 334
contacts lower extension member 320 as well as ablation region 318.
Passive or active actuation of ablation region 318 may then injure
and/or remove the target mucosal tissue 334. As further seen in
FIG. 15C, this procedure may be repeated at one or more additional
tissue folds 336, 338 that may then be approximated together, as in
FIG. 15D. The contacting injured regions of mucosal tissue promote
healing and fusion 340 of the approximated folds, as in FIG.
15E.
[0118] Aside from variations on aspects of the tissue manipulation
assembly, the entire assembly may also be modified to adjust the
tissue manipulation assembly position relative to the tubular body
upon which the assembly is attachable. FIG. 16A shows a distal
portion of tubular body 12 and tissue manipulation assembly 14
connected thereto. While tubular body 12 may comprise a rigid or
flexible length, tissue manipulation assembly 14 may be further
configured to articulate relative to tubular body 12, as shown in
FIG. 16B, to further enhance the maneuverability and manipulation
capabilities of tissue manipulation assembly 14. In one example,
assembly 14 may be connected to tubular body 12 via a hinged or
segmented articulatable portion 350, shown in the detail FIG. 16C,
which allows assembly 14 to be reconfigured from a low-profile
configuration straightened relative to tubular body 12 to an
articulated configuration where assembly 14 forms an angle,
.alpha., relative to tubular body 12. The angle, .alpha., may range
anywhere from 180.degree. to -180.degree. depending upon the
desired level of articulation. Articulatable portion 350 may be
configured to allow assembly 14 to become articulated in a single
plane or it may also be configured to allow a full range of motion
unconstrained to a single plane relative to tubular body 12.
Articulation of assembly 14 may be accomplished any number of
various methods, e.g., control wires.
[0119] The tissue manipulation assembly may be manipulated and
articulated through various mechanisms. One such assembly that
integrates each of the functions into a singular unit may be seen
in the handle assembly 16, which is connected via tubular body 12
to the tissue manipulation assembly. Such a handle assembly may be
configured to separate from tubular body 12, thus allowing for
reusability of the handle. Moreover, such a handle may be
fabricated from a variety of materials such as metals or plastics,
provided that the materials are preferably biocompatible. Examples
of suitable materials may include stainless steel, PTFE,
Delrin.RTM., etc.
[0120] One variation of a handle assembly 16 is shown in the
illustrative side view of handle 500 in FIG. 17A with half of
handle enclosure 502 removed for clarity for discussion purposes.
As shown, handle enclosure 502 may connect with tubular body 12 at
its distal end at tubular interface 504. The proximal end of handle
500 may define acquisition member opening 506 which opens to
acquisition member receiving channel 508 defined through enclosure
502 from opening 506 to tubular interface 504. The acquisition
member 28 may be routed through receiving channel 508 with the
proximal end 510 of acquisition member 28 extending proximally of
enclosure 502 for manipulation by the user. Acquisition member
proximal end 510 may further have an acquisition member rotational
control 512 that the user may grasp to manipulate acquisition
member 28.
[0121] Acquisition member receiving channel 508 preferably has a
diameter which is sufficiently large enough to allow for the
translational and rotational movement of acquisition member through
the receiving channel 508 during tissue manipulation. Acquisition
member lock 524, e.g., a screw or protrusion, may also extend at
least partially into acquisition member receiving channel 508 such
that lock 524 may be urged selectively against acquisition member
28 to freeze a position of acquisition member 28, if so desired.
The terminal end of receiving channel 508 may extend to tubular
interface 504 such that receiving channel 508 and tubular body 12
are in communication to provide for the passage of acquisition
member 28 therethrough.
[0122] In addition to the acquisition member controls, the handle
enclosure 502 may also provide a needle assembly receiving channel
514 through which needle assembly control 516 and needle assembly
catheter 518 may be translated through. Needle assembly receiving
channel 514 may extend from needle assembly opening 520 also to
tubular interface 504. Needle assembly receiving channel 514
extends to tubular interface 504 such that needle assembly
receiving channel 514 and tubular body 12 are also in communication
to provide for the passage of needle assembly catheter 518
therethrough.
[0123] In operation, once the tissue to be plicated has been
acquired and drawn between the lower and upper extension members by
acquisition member 28, as described above, the launch tube 18 may
be advanced distally and rotated into its deployment configuration.
Once positioned for deployment, the needle assembly may be advanced
into and/or through the tissue by urging needle assembly control
516 and needle assembly catheter 518 distally into needle assembly
receiving channel 514, as shown by the advancement of control 516
in FIG. 17B. The tissue anchors may then be deployed from the
needle assembly catheter 518 via the needle assembly control 516,
as further described below. Withdrawal of the needle assembly from
the tissue may be accomplished by the proximal withdrawal of needle
assembly control 516 and assembly catheter 518.
[0124] Tissue manipulation articulation control 522 may also be
positioned on handle 500 to provide for selective articulation of
the tissue manipulation assembly, as shown above in FIGS. 16A to
16C. This variation shows articulation control 522 rotatably
positioned on handle enclosure 502 such that articulation control
522 may be rotated relative to handle 500 to selectively control
the movement of the tissue manipulation assembly. Articulation
control 522 may be operably connected via one or several control
wires attached between articulation control 522 and the tissue
manipulation assembly. The control wires may be routed through
tubular interface 504 and extend through tubular body 12.
[0125] FIG. 17C shows another variation of handle enclosure 502
where the tissue manipulation articulation control 526 may be
positioned on a side surface of handle enclosure 502. Articulation
control 526 may include a ratcheting mechanism 528 within enclosure
502 to provide for controlled articulation of the tissue
manipulation assembly.
[0126] FIGS. 18A to 18C show top, side, and cross-sectional views,
respectively, of another variation on the handle assembly. As seen
in FIGS. 18A and 18B, an advancement control 530 may be adapted to
selectively slide translationally and rotationally through a
defined advancement channel or groove 532 defined within handle
enclosure 502. Advancement control 530 may be used to control the
deployment and advancement of needle assembly control 516 as well
as deployment of the launch tube, as described in further detail
below.
[0127] FIG. 18D shows an assembly side view of the handle assembly,
tubular body 12, and tissue manipulation assembly and the
corresponding motion of the assembly when manipulated by the
handle. As described above, tissue acquisition member proximal end
510 and acquisition member control 512 may be advanced or withdrawn
from the handle enclosure 502 in the direction of arrow 534 to
transmit the corresponding translational motion through tubular
body 12 to tissue acquisition member 28 and tissue grasper 30, as
indicated by the direction of corresponding arrow 536. Likewise,
when acquisition member control 512 is rotated relative to handle
enclosure 502, as indicated by rotational arrow 538, the
corresponding rotational motion is transmitted through tubular body
12 to tissue grasper 30 for screwing into or unscrewing from
tissue, as indicated by corresponding rotational arrow 540. As
mentioned above, tubular body 12 may be rigid or flexible depending
upon the application utilized for the device.
[0128] Likewise, longitudinal translation of needle assembly
control 516 relative to enclosure 502, as indicated by the arrow
may transmit the corresponding longitudinal motion to the needle
assembly through the launch tube when reconfigured for deployment.
The tissue manipulation assembly articulation control 522 may also
be seen in this handle variation as being rotatable in the
direction of arrow 542 relative to handle enclosure 502. Depending
upon the direction of articulation, control 522 may be manipulated
to elicit a corresponding motion from the tissue manipulation
assembly about hinge or articulatable section 350 in the direction
of arrows 544.
[0129] Another handle variation may be seen in the perspective view
of handle assembly 550, as shown in FIG. 19A. This particular
variation may have handle enclosure 552 formed in a tapered
configuration which allows for the assembly 550 to be generally
symmetrically-shaped about a longitudinal axis extending from its
distal end 554 to its proximal end 556. The symmetric feature of
handle assembly 550 may allow for the handle to be easily
manipulated by the user regardless of the orientation of the handle
enclosure 552 during a tissue manipulation procedure. An additional
feature which may further facilitate the ergonomic usability of
handle assembly 550 may further include at least one opening 558
defined through the enclosure 552 to allow the user to more easily
grip and control the handle 550. Another feature may include grips
560, 562 which may extend from either side of enclosure 552.
[0130] As seen in the figure, acquisition member 564 may include
additional features to facilitate control of the tissue. For
instance, in this variation, in addition to the rotational control
566, an additional rotational control 568 may extend proximally
from control 566 and have a diameter smaller than that of control
566 for controlling fine rotational motion of acquisition member
564.
[0131] FIG. 19B shows a side view of the handle assembly 550 of
FIG. 19A with the enclosure 552 partially removed for clarity. As
shown, needle assembly control 570 may be seen inserted within an
additional needle deployment mechanism 576, as described below in
further detail, within needle assembly receiving channel 574.
Acquisition member 564 may also be seen positioned within
acquisition member receiving channel 572.
[0132] Yet another variation of the handle assembly may be seen in
the side view of the handle assembly of FIG. 20A where the handle
enclosure 522 is partially removed for clarity. In this variation,
needle deployment mechanism lock 580, e.g., a screw or protrusion,
may be configured to operably extend at least partially into needle
assembly receiving channel 574 to selectively lock the launch tube
and/or needle assembly control within receiving channel 574. Also
shown is acquisition member receiving channel 582 through which the
acquisition member may be translated and/or rotated. Acquisition
member lock 584 may also be seen to extend at least partially into
the acquisition member receiving channel 582 to selectively lock
the acquisition member position, if so desired. The acquisition
member receiving channel 582 may be optionally threaded 586 such
that the acquisition member may be advanced or withdrawn using a
screw-like mechanism.
[0133] An additional needle deployment mechanism lock 594 may also
be seen pivotally mounted about pivot 596 within enclosure 522.
Mechanism 594 may be biased via deployment mechanism biasing
element 598, e.g., a spring, to maintain a biasing force against
mechanism 594 such that the needle assembly control may
automatically become locked during advancement within enclosure 522
to allow for a more controlled anchor deployment and needle
assembly advancement.
[0134] Moreover, one or more pivotable tissue manipulation assembly
controls 588 may be mounted to enclosure 522 and extend from one or
both sides of enclosure 522 to provide for articulation control of
the tissue manipulation assembly, as described above. As presently
shown in FIG. 20B in the detail side view from the handle assembly
of FIG. 20A, one or more control wires 592 may be connected to
control 588 at control wire attachment points 600. Control 588 may
pivot about tissue acquisition pivot 590 located within handle
enclosure 522. As control 588 is pivoted, the articulation of
control wires 592 may articulate a position of the tissue
manipulation assembly, as discussed above. FIG. 20B shows an
example of the range of motion which may be possible for control
588 as it is rotated about pivot 590.
[0135] FIG. 21A shows a side view of another variation of handle
enclosure 610 which incorporates a needle deployment locking and
advancement control 612 which is adapted to be advanced and rotated
within needle deployment travel 614 into various positions
corresponding to various actions. Locking control 612 may be
utilized in this variation to selectively control access of the
needle assembly within handle enclosure 610 as well as deployment
of the needle assembly and launch tube advancement with a single
mechanism. A needle assembly, such as needle assembly 570, may be
advanced into handle enclosure 610 with locking control 612
initially moved into needle assembly receiving position 616, shown
also in the end view of FIG. 21B. Once the needle assembly has been
initially introduced into enclosure 610, the needle assembly may be
locked within enclosure 610 by rotating locking control 612 into
its needle assembly locking position 618, clockwise rotation as
shown in the end view of FIG. 21C. The needle assembly may be
locked within enclosure 610 to prevent the accidental withdrawal of
the needle assembly from the enclosure 610 or inadvertent
advancement of the needle assembly into the tissue.
[0136] With locking control 612 in the needle assembly locking
position 618, the needle deployment mechanism within enclosure 610
may also be longitudinally translated in a distal direction by
urging locking control 612 distally within needle deployment travel
614. Urging locking control 612 distally translates not only the
needle deployment mechanism within enclosure 610, but may also
translate the launch tube distally such that the launch tube distal
portion is pivoted into its deployment configuration, as described
above. As the needle deployment mechanism is distally translated
within enclosure 610, the needle assembly may also be urged
distally with the deployment mechanism such that needle assembly
becomes positioned within the launch tube for advancing the needle
body into the tissue.
[0137] Once locking control 612 has been advanced distally, locking
control 612 may again be rotated into the needle assembly release
position 620, clockwise rotation as shown in the end view of FIG.
21D. Once in the release position 620, the needle assembly may be
free to be translated distally within enclosure 610 for advancing
the needle assembly and needle body relative to the launch tube and
enclosure 610. To remove the needle assembly from enclosure 610,
the steps may be reversed by moving locking control 612 proximally
back to its initial needle assembly receiving position 616 so that
the needle assembly is unlocked from within enclosure 610. A new
needle assembly may then be introduced into enclosure 610 and the
process repeated as many times as desired.
[0138] Details of one variation of the locking mechanism disposed
within the handle enclosure 610 are shown in the perspective view
of FIG. 22A. The other elements of the handle assembly have been
omitted from this illustration for clarity. The locking mechanism
may generally be comprised of outer sleeve 630 disposed about inner
sleeve 632. Outer sleeve 630 preferably has a diameter which allows
for its unhindered rotational and longitudinal movement relative to
inner sleeve 632. Needle deployment locking control 612 may extend
radially from outer sleeve 630 and protrude externally from
enclosure 610, as described above, for manipulation by the user.
Outer sleeve 630 may also define needle assembly travel path 636
along its length. Travel path 636 may define the path through which
needle assembly 570 may traverse in order to be deployed. Needle
assembly 570 may define one or more guides 638 protruding from the
surface of assembly 570 which may be configured to traverse within
travel path 636. Inner sleeve 634 may also define guides 634
protruding from the surface of inner sleeve 634 for traversal
within grooves defined in handle enclosure 610. Moreover, outer
sleeve 630 is preferably disposed rotatably about inner sleeve 632
such that outer sleeve 630 and inner sleeve 632 are configured to
selectively interlock with one another in a corresponding manner
when locking control 612 is manipulated into specified
positions.
[0139] Turning to FIGS. 22B to 22E, the operation of the locking
mechanism of FIG. 22A is described in further detail. As needle
assembly 570 is initially introduced into handle enclosure 610 and
the locking mechanism, needle assembly 570 may be rotated until
guides 638 are able to slide into longitudinal receiving channel
640 of travel path 636 defined in outer sleeve 630, as shown in
FIGS. 22B and 22C. Locking control 612 may be partially rotated, as
described above in FIGS. 21B and 21C, such that outer sleeve is
rotated with respect to needle assembly 570 and guides 638 slide
through transverse loading channel 642, as shown in FIG. 22D. In
this position, the locking mechanism may be advanced distally to
deploy the launch tube and to also advance needle assembly 570
distally in preparation for needle assembly 570 deployment. Once
the launch tube has been desirably advanced, locking control 612
may again be partially rotated, as shown in FIG. 21D, such that
guides 638 on needle assembly 570 are free to then be advanced
within longitudinal needle assembly channel 644 relative to the
handle enclosure 610 for deploying the needle assembly 570 from the
launch tube and into or through the tissue. As mentioned above, the
needle assembly 570 may be removed from enclosure 610 and the
locking mechanism by reversing the above procedure.
[0140] As described above, needle deployment assembly 650 may be
deployed through approximation assembly 10 by introducing needle
deployment assembly 650 into the handle 16 and through tubular body
12, as shown in the assembly view of FIG. 23, such that the needle
assembly 656 is advanced from the launch tube and into or through
approximated tissue. Once the needle assembly 656 has been advanced
through the tissue, the anchor 30 assembly 658 may be deployed or
ejected. Anchor assembly 658 is normally positioned within the
distal portion of tubular sheath 654 which extends from needle
assembly control or housing 652. Once the anchor assembly 658 has
been fully deployed from sheath 654, the spent needle deployment
assembly 650 may be removed from approximation assembly 10, as
described above, and another needle deployment assembly may be
introduced without having to remove assembly 10 from the patient.
The length of sheath 654 is such that it may be passed entirely
through the length of tubular body 12 to enable the deployment of
needle assembly 656 into and/or through the tissue.
[0141] FIG. 24A shows a detailed assembly view of the needle
deployment assembly 650 from FIG. 23. In this variation, elongate
and flexible sheath or catheter 654 may extend removably from
needle assembly control or housing 652. Sheath or catheter 654 and
housing 652 may be interconnected via interlock 660 which may be
adapted to allow for the securement as well as the rapid release of
sheath 654 from housing 652 through any number of fastening
methods, e.g., threaded connection, press-fit, releasable pin, etc.
Needle body 662, which may be configured into any one of the
variations described above, may extend from the distal end of
sheath 654 while maintaining communication between the lumen of
sheath 654 and needle opening 664.
[0142] Elongate pusher 666 may comprise a flexible wire or hypotube
which is translationally disposed within sheath 654 and movably
connected within housing 652. A proximally-located actuation member
668 may be rotatably or otherwise connected to housing 652 to
selectively actuate the translational movement of elongate pusher
666 relative to sheath 654 for deploying the anchors from needle
opening 664. Anchor assembly 658 may be seen positioned distally of
elongate pusher 666 within sheath 654 for deployment from sheath
654. Needle assembly guides 670 may also be seen protruding from
housing 652 for guidance through the locking mechanism described
above. FIG. 24B shows an exploded assembly view of the needle
deployment assembly 650 from FIG. 24A. As seen, sheath 654 may be
disconnected from housing 652 via interlock 660 to reveal the
elongate pusher 666 connected to housing 652 and the distal and
proximal anchors 58, 60, respectively, of anchor assembly 658.
[0143] FIGS. 25A and 25B show partial cross-sectional views of one
variation of housing 652. As shown in FIG. 25A, elongate pusher 666
may be attached to shuttle 682, which in turn may be connected to
threaded interface element 686. As actuation member 668 is
manipulated, e.g., by rotating it clockwise, lead screw 684 may be
rotated about its longitudinal axis to advance threaded interface
element 686 over lead screw 684 distally through shuttle channel
680, as shown in FIG. 25B, where shuttle 682 has been advanced
entirely through shuttle channel 680. Tubular sheath interlock 688
may be seen at the distal portion of housing 652 through which the
elongate pusher 666 may be advanced. To reverse the direction of
elongate pusher 666 and shuttle 682, actuation member 668 may be
reversed in the opposite direction.
[0144] Another variation of the needle deployment assembly may be
seen in FIGS. 26A and 26B which show assembly side views. In this
variation, housing 652 may define an indicator window 690 along the
length of housing 652 to enable viewing of a visual indicator 692
which may be utilized to indicate the position of the elongate
pusher 666 within the sheath 654. In the illustration of FIG. 26A,
as actuation member 668 is manipulated to advance pusher 666
distally, indicator 692 may move correspondingly within window 690.
Positional indicators may also be marked along window 690 to
indicate to the user when specified limits have been reached. For
instance, positional indicator 694 may be marked such that
alignment of indicator 692 with positional indicator 694 is
indicative to the user that distal anchor 58 has been deployed from
sheath 654.
[0145] Likewise, an additional positional indicator 696 may be
marked such that alignment of indicator 692 with positional
indicator 694 is indicative to the user that the proximal anchor 60
has also been deployed from sheath 654, as shown in FIG. 26B. Any
number of positional indicators or methods for visually marking may
be utilized as the above examples are merely intended to be
illustrative and not limiting. Moreover, to further facilitate the
visualization of anchor positioning within sheath 654, the sheath
itself may be fabricated from a transparent material, such as
plastics, so that the user may visually locate a position of one or
both anchors during anchor deployment into or through the
tissue.
[0146] FIG. 26C shows an illustrative cross-sectional view of the
launch tube 18 in its deployment configuration. Tubular sheath 654
and needle body 662 may be seen positioned within the distal
portion of launch tube 18 ready for deployment into any tissue (not
shown for clarity) which may be positioned between upper and lower
extension members 20, 26. Also shown are distal and proximal
anchors 58, 60, respectively (suture is not shown for clarity),
positioned within sheath 654 distally of elongate pusher 666.
[0147] Various force transmission elements or configurations may be
provided to actuate elements of end effectors. Such end effectors
may, for example, comprise previous described end effector 14, or
any alternative medical end effector. Referring to FIG. 27, an
embodiment of apparatus 10 is provided comprising flexible tubular
body 12 that couples end effector 14 to handle 500. Force
transmission elements, such as those described previously and/or
those described hereinafter, optionally may be integrated into,
and/or actuable via, the handle.
[0148] With reference to FIG. 28, a first embodiment of such a
force transmission element illustratively is shown actuating a
tissue acquisition member that may, for example, be utilized as
part of end effector 14 of apparatus 10. As will be apparent, the
force transmission element (as with other force transmission
elements described hereinafter) optionally may be utilized to
actuate other elements of end effector 14 of apparatus 10, or of
some other medical end effector. Tissue acquisition member 700
comprises elongated member 710 disposed within outer sheath 720.
Outer sheath 720 optionally may comprise locally necked-down distal
region 722 that acts as a bearing surface for rotation and/or
translation of elongated member 710. Elongated member 710 comprises
distal tissue grasper 712, illustratively a helical tissue grasper.
As illustrated by arrows in FIG. 28, rotation of a proximal region
of member 710 transmits a rotational torque to distal tissue
grasper 712. Likewise, translation of the proximal region
translates the grasper. Member 710 optionally may be
translationally (or rotationally) fixed relative to outer sheath
720, e.g., fixed at necked down distal region 722 of the outer
sheath. It should be understood that outer sheath 720 optionally
may comprise the working channel of an endoscope or other medical
instrument, per se known.
[0149] Referring now to FIG. 29, a force transmission element that
transmits and converts rotational motion into translation motion
via a lead screw mechanism is described. In FIG. 29, tissue
acquisition member 700 comprises elongated member 710' having
distal lead screw 714. Tissue grasper 712' comprises mating screw
716. As seen in FIG. 29A, rotation of a proximal region of member
710' in a first direction translationally advances tissue grasper
712' relative to outer sheath 720 via the lead screw coaction of
distal screw 714 of elongated member 710' with mating screw 716 of
tissue grasper 712'. Likewise, as seen in FIG. 29B, rotation of the
proximal region of member 710' in the opposite direction actuates
the lead screw to translationally retract grasper 712' relative to
outer sheath 720.
[0150] With reference to FIG. 30, tissue acquisition member 700
converts rotational motion into translational motion that actuates
a linkage to initiate a more complex motion. In FIG. 30, the male
and female elements of the lead screw have been reversed.
Specifically, tissue grasper 730 comprises member 732 having male
screw 714, while elongated member 710' comprises female mating
screw 716. It should be understood that the screw elements may be
reversed, as desired.
[0151] Tissue grasper 730 may further comprise four bar linkage 734
having first and second bars 735a and 735b, respectively, that are
coupled at pivot 740 to member 732. The four bar linkage further
comprises third and fourth bars 736a and 736b, respectively, that
are coupled to the first and second bars at pivots 742a and 742b,
respectively. The third and fourth bars cross and are pivotally
attached to one another, as well as to sheath 720, at pivot 744.
First and second jaw members 738a and 738b extend from (or are
integrally formed with) the third and fourth bars, respectively,
for grasping tissue.
[0152] As seen in FIG. 30A, rotation of a proximal region of member
710' in a first direction translationally advances member 732 of
tissue grasper 730 relative to sheath 720 and/or elongated member
710' via the coacting lead screw. Advancement of member 732
actuates four bar linkage 734 in a manner that separates and opens
jaw members 738a and 738b, e.g., for engaging or releasing engaged
tissue. As seen in FIG. 30B, rotation of member 710' in an opposite
direction translationally retracts member 732 of grasper 730
relative to sheath 720/member 710'. This actuates four bar linkage
734 in a manner that approximates and closes jaw members 738, e.g.,
to secure engaged tissue therebetween or to provide a lower profile
delivery or retrieval configuration.
[0153] Referring to FIG. 31, an alternative embodiment of the
apparatus of FIG. 30 is described. In FIG. 31, tissue acquisition
member 700 comprises tissue manipulation assembly 730' rather than
tissue grasper 730. Specifically, jaw members 738 of grasper 730
have been replaced with first and second extension members 738'.
First extension member 738a' may extend from third bar 736a of four
bar linkage 734, while second extension member 738b' may likewise
extend from second bar 735b of the linkage. As seen in FIG. 31,
rotation of member 710' advances or retracts member 732, which
actuates four bar linkage 734 and reorients the extension members
relative to sheath 720.
[0154] In the embodiment of FIG. 31, a separation distance between
the extension members may vary during actuation of linkage 734 and
reorientation of the extension members. FIG. 32 provide apparatus
and a method for coordinated reorientation or pivoting of extension
members of a tissue manipulation assembly, whereby the separation
distance between the extension members does not vary. Apparatus 800
comprises sheath 810 having first and second guide lumens 812a and
812b, respectively, disposed within the wall of the sheath.
Elongated members 820a and 820b having first and second lead screws
822a and 822b, respectively, are disposed within guide lumens 812.
Extension members 830 are integrally formed into a U-shaped
structure that is connected to gear 840 at attachment 832.
Attachment 832 may pivotably attach the gear and extension members
to sheath 810. Gear 840 comprises teeth 842 that are configured to
coact with lead screws 822.
[0155] As illustrated by arrows in FIG. 32B, coordinated rotation
of elongated members 820a and 820b in opposing directions pivots or
reorients extension members 830 relative to sheath 810 via coaction
of gear teeth 842 with lead screws 822. As will be apparent,
extension members 830 alternatively may be reoriented via coaction
of gear 840 with a single lead screw 822. Furthermore, a medical
practitioner may actively rotate only a single elongated member
820, and the secondary elongated member 820 may passively rotate in
an opposing direction via interaction of its lead screw with the
gear. Furtherstill, the first and second elongated members 820 may
be rotated in the same direction, or one of the elongated members
may be held stationary while the other is rotated, in order to
friction lock an orientation or position of extension members 830
relative to sheath 810.
[0156] Referring now to FIG. 33, hydraulic rotation of extension
members 830 is described. In FIG. 33, extension members 830 are
coupled to fluid wheel or turbine 850. Fluid wheel 850 comprises
multiple extensions or spokes 852 that facilitate hydraulic
rotation of the wheel. The fluid wheel and extension members 830
may be pivotably attached to sheath 860 at pivot 862. Sheath 860
comprises fluid channel 864 having fluid F disposed therein. Spokes
852 of fluid wheel 850 communicate with channel 864. As illustrated
by arrows in FIG. 33B, fluid F may be forced through channel 864
under pressure to apply a hydraulic moment to spokes 852 of wheel
850 that rotates the wheel about pivot 862 in the direction of
fluid flow. Rotation of wheel 850 rotates and reorients extension
members 830 that are attached to the wheel relative to sheath
860.
[0157] With reference to FIG. 34, independent hydraulic rotation of
each of the extension members is described. Extension members 870a
and 870b comprise fluid wheels 872a and 872b, respectively, having
spokes 874a and 874b, respectively. Wheels 872a and 872b are
pivotably coupled to sheath 860 at pivots 876a and 876b,
respectively, which are disposed in fluid channel 864 of sheath
860. Pressurized flow of fluid F through channel 864 applies
hydraulic moments to spokes 874a and 874b of the fluid wheels that
rotate the wheels about pivots 876 in the direction of fluid flow.
Rotation of wheels 872a and 872b independently rotates and
reorients extension members 870a and 870b relative to sheath
860.
[0158] Referring now to FIG. 35, hydraulic actuation of a tissue
acquisition member or tissue grasper is described. Helical tissue
grasper 880 comprises shaft 882 having propeller 884 disposed
within fluid channel 864 of sheath 860. Helical grasper 880 is
configured for rotation within extension 866 of sheath 860.
Pressurized flow of fluid F through channel 864 rotates propeller
884, which in turns rotates helical tissue grasper 880. Fluid F
may, for example, flow through channel 864 in a first direction to
rotate helical grasper 880 in a direction appropriate for engaging
tissue, and may flow in an opposing direction to rotate the helical
grasper in an opposing direction appropriate for disengaging the
tissue.
[0159] With reference to FIG. 36, fluid wheel or gear 890 having
spokes or teeth 892 is pivotably coupled to sheath 860 at pivot 894
disposed within channel 864. Helical grasper 900 comprises shaft
902 having proximal corrugations or protrusions 904 that are
configured to coact with teeth 892 of fluid gear 890. As
illustrated in FIG. 36B, pressurized flow of fluid F in a first
direction through channel 864 applies a moment to teeth 892 of gear
890 that rotates the gear about pivot 894. This rotation advances
helical grasper 900 relative to sheath 860 via coaction of teeth
892 of gear 890 with corrugations 904 of shaft 902 of grasper 900.
Fluid flow through channel 864 in an opposing direction would
retract grasper 900 relative to sheath 860 in a similar
fashion.
[0160] Referring now to FIG. 37, motor-actuated force transmission
elements for advancing and rotating an end effector element are
described. Helical tissue acquisition member or grasper 950
comprises shaft 952 that is proximally coupled to drive shaft 962
of first electric motor 960. Motor 960 is slidably disposed within
sheath 980 and comprises mating screw 964 that is configured to
coact with lead screw drive shaft 972 of second electric motor 970.
Second motor 970 is coupled to sheath 980. First motor 960
comprises positive and negative electrical hook-ups 966, while
second motor 970 comprises electrical hook-ups 976.
[0161] A current passed through first motor 960 via electrical
hook-ups 966 rotates the motor's drive shaft 962, which rotates
helical grasper 950. Reversing the polarity of current passed
through motor 960 reverses the direction of rotation of grasper
950. Passage of a current through second motor 970 via electrical
hook-ups 976 rotates lead screw drive shaft 972, which coacts with
mating screw 964 of first motor 960 to advance or retract the first
motor relative to sheath 980, thereby advancing or retracting
helical tissue grasper 950 relative to the sheath.
[0162] With reference to FIG. 38, a motor-actuated jaw tissue
grasper is described. Tissue grasper 1000 comprises first and
second jaws 1002a and 1002b, respectively, having interdigitating
distal teeth 1004 for engaging tissue. Jaws 1002 further comprise
proximal gears 1006 having teeth 1008 that are configured to coact
with lead screw drive shaft 1012 of electric motor 1010. Gears 1006
are pivotably connected to sheath 1016 at pivots 1007. Motor 1010,
which is coupled to sheath 1016, comprises electrical hook-ups
1014, and passage of an electrical current through the motor via
the hookups rotates lead screw drive shaft 1012. Coaction of gear
teeth 1008 with the rotating lead screw acts to approximate or
separate first and second jaws 1002, depending on the polarity of
the current passed through the motor.
[0163] Referring to FIG. 39, a motor-actuated four-bar linkage is
described. Linkage 1020 comprises first and second bars 1022a and
1022b, respectively, that are coupled at pivot 1032 to nut member
1030. The four bar linkage further comprises third and fourth bars
1024a and 1024b, respectively, that are coupled to the first and
second bars at pivots 1026a and 1026b, respectively. The third and
fourth bars cross and are pivotably attached to one another, as
well as to sheath 1040, at pivot 1042. Sheath 1040 comprises
through-holes, side-ports or windows (not shown) that accommodate
expansion of four bar linkage 1020.
[0164] Nut member 1030 is concentrically disposed about, and
comprises a mating screw adapted to coact with, lead screw drive
shaft 1052 of electric motor 1050. Motor 1050 is coupled to sheath
1040, and it comprises electrical hook-ups 1054. Passage of an
electrical current through the motor via the hook-ups rotates lead
screw drive shaft 1052, which advances or retracts nut member 1030
relative to the drive shaft, dependent on the direction of rotation
of the drive shaft. As seen in FIG. 39B, advancement of the nut
member actuates linkage 1020 in a manner that shortens and expands
the linkage.
[0165] Referring now to FIG. 40, a force transmission element
comprising a column of ball-bearings is described. The apparatus of
FIG. 40 is substantially the same as the apparatus of FIG. 33,
except that channel 864 of sheath 860 is filled with
collinearly-aligned ball-bearings 1100, rather than fluid F. As
illustrated by arrows in FIG. 40B, the column of ball-bearings 1100
may be pushed through channel 864 to apply a moment to spokes 852
of wheel 850 that rotates the wheel about pivot 862 in the
direction of motion of the ball-bearing column. Rotation of wheel
850 rotates and reorients extension members 830 that are attached
to the wheel relative to sheath 860.
[0166] With reference now to FIG. 41, crimping or grasping via a
ball-bearing column is described. Crimping jaws 1200a and 1200b are
pivotably connected to one another and to sheath 1210 at pivot
1212. Each crimping jaw comprises a distal crimping surface 1202
and a proximal mating screw 1204. The proximal mating screws are
coaxially disposed over rod 1220 having first and second
oppositely-turned lead screws 1222a and 1222b that are configured
to coact with mating screws 1204. Rod 1220 is rotatably coupled to
sheath 1210, and rotation of the rod causes crimping jaws 1200a and
1200b to move in opposite directions (either towards one another or
away from one another) via the lead screws. The previously
described column of ball-bearings 1100 is also provided, either
with a channel of sheath 1210 or within their own malleable sleeve.
The column of ball-bearings extends around and contacts a central
region of rod 1220.
[0167] As seen in the detail view of FIG. 41, the central region of
rod 1220 comprises profiled surface 1224 having multiple divots
configured for placement of a ball bearing therein. In this manner,
ball-bearing column 1100 engagingly contacts rod 1220, such that
movement of the column rotates the rod. As mentioned, such rotation
opens or closes jaws 1200, dependent upon the direction of
rotation. Jaws 1200 may, for example, be spread apart for placement
of a crimp therebetween, then approximated to deform the crimp.
Such crimping may be controlled from a proximal location by a
medical practitioner via the column of ball-bearings.
[0168] Referring now to FIG. 42, a force transmission mechanism
utilizing geometric constraints is described. Grasper or crimper
1300 comprises jaws 1302a and 1302b that are pivotably joined at
pivot 1304 and are biased into a spread or open configuration, e.g.
via a spring. Proximal extension 1306 extends from pivot 1304, and
wire 1308 extends proximally from extension 1306. Wire 1308 extends
through tube 1310. Grasper 1300 is disposed within sheath 1320
having conical or wedge-shaped distal insert 1322 through which
proximal extension 1306 of the grasper extends.
[0169] Jaws 1302 of grasper 1300 may be advanced out of sheath 1320
by advancing tube 1310 against extension 1306 of the grasper. Such
advancement of the grasper may be achieved by a medical
practitioner advancing a proximal portion of the tube disposed
outside of a patient. As seen in FIG. 42A, jaws 1302 spread apart
to their biased, open configuration. The jaws then may be
approximated, e.g., to engage tissue or deform a crimp, by
retracting wire 1308 from outside the patient, such that the jaws
contact distal insert 1322 of sheath 1320 and are urged together
into an approximated configuration, as in FIG. 42B.
[0170] Referring now to FIG. 43, a method of deforming a crimp with
a linkage assembly is described. The apparatus of FIG. 43 is
similar to that of FIG. 39. Previously-described linkage 1020 is
proximally coupled at pivot 1032 to nut member 1030, and is
distally coupled at pivot 1042 to sheath 1400. Nut member 1030 is
concentrically disposed about, and comprises a mating screw adapted
to coact with, lead screw 1412 of elongated member 1410. Extension
member 1420 is coupled to nut member 1030 and is slidably disposed
within linear bearings 1402 of sheath 1400. Rotation of elongated
member 1410 advances or retracts nut member 1030 along the lead
screw, which, in turn, advances or retracts extension member 1420
and expands or collapses linkage 1020.
[0171] As seen in FIG. 43A, a distal end of sheath 1400 may be
disposed in proximity to crimp 1500 having suture S running
therethough. In FIG. 43B, the crimp may be disposed within open
chamber 1404 of the sheath and may be deformed by rotating
elongated member 1410 to actuate the lead screw, which expands
linkage 1020 and urges member 1420 against the crimp. Linkage 1020
then may be collapsed, and member 1420 may be moved proximally, by
rotating elongated member 1410 in the opposite direction to actuate
the lead screw in a manner that retracts nut member 1030 relative
to sheath 1400. As seen in FIG. 43C, deformed crimp 1500 then may
be removed from chamber 1404. Thereafter, the deformed crimp will
maintain the position of suture S relative to the crimp. As seen in
the detail view of FIG. 43D, a similar deformation mechanism may be
achieved with a two bar embodiment of linkage 1020, as well as with
the top portion of chamber 1404 and/or at least one of the linear
bearings 1402 removed.
[0172] With reference to FIG. 44, an alternative embodiment of the
apparatus and method of FIG. 43 is described. As seen in FIGS. 43B
and 43C, linkage 1020 may be used to form a single kink in crimp
1500. However, multiple linkages may be provided to form multiple
kinks in the crimp. It is expected that providing multiple kinks in
the crimp will produce a more tortuous path through the crimp,
e.g., a more tortuous path for passage of suture S through crimp
1500 that will better maintain the position of the suture relative
to the crimp.
[0173] In FIG. 44, first and second linkages 1020a and 1020b
illustratively are provided to form first and second kinks or bends
in crimp 1500. First and second elongated members 1410 having first
and second lead screws 1412 are also provided. As illustrated in
FIG. 44, the linkages may be coupled to extension member 1420, or
may move independently along the lead screws via nut members 1030.
As seen in FIG. 44A, crimp 1500 may be disposed between linkages
1020a and 1020b. The linkages then may be expanded to deform the
crimp with multiple kinks or bends, as in FIG. 44B.
[0174] Referring now to FIG. 45, a four-bar linkage actuated via
linear or translational motion is described. Linkage 1020' is
similar to linkage 1020 and comprises first and second bars 1022a
and 1022b, respectively, that are coupled at pivot 1032 to piston
member 1030'. The four bar linkage further comprises third and
fourth bars 1024a and 1024b, respectively, that are coupled to the
first and second bars at pivots 1026a and 1026b, respectively. The
third and fourth bars cross and are pivotably attached to one
another, as well as to sheath 1040, at pivot 1042. Sheath 1040
comprises through-holes, side-ports or windows (not shown) that
accommodate expansion of four bar linkage 1020'.
[0175] Piston member 1030' is coupled to push-pull member 1600,
which extends through sheath 1040 to a proximal region, where it
may be manipulated by a medical practitioner. As seen in FIG. 45B,
advancement of push-pull member 1600 relative to sheath 1040
advances piston member 1030', which in turn actuates linkage 1020'
in a manner that shortens and expands the linkage. Subsequent
retraction of member 1600 relative to the sheath retracts the
piston member, which elongates and collapses the linkage back to
the delivery configuration of FIG. 45A. As will be apparent, jaw
members or graspers, extension members, or any other end effector
may be coupled to, and/or actuated by, linkage 1020'.
[0176] A variety of transmission mechanisms have been described for
transmitting force, energy and/or power along desired vectors over
significant distances from a medical practitioner to an end
effector. It should be understood that the embodiments are provided
for illustration only, and elements of the embodiments may be used
in any combination as practicable. FIG. 46 provides a schematic
representation for a generic transmission mechanism. A medical
practitioner positioned at location A transmits force, energy
and/or power to an end effector disposed at position B. The
direction or type of the force/power/energy may be converted at or
in the vicinity of position B to a form or direction appropriate
for actuating the end effector. For example, force may be converted
from rotational to translational, or vice versa. Additionally or
alternatively, energy may be converted from electrical or fluid to
mechanical, etc.
[0177] A variety of mechanisms, per se known, may be utilized to
transmit force/power/energy from the medical practitioner to the
end effector. These include, but are not limited to, hydraulic
pumps; fluid compressors; pressure tanks; condensate separators and
drain valves; compressed air systems, regulators or valves;
hydraulic cylinders; electromechanical and/or linear actuators and
solenoids; electric or air motors; speed reducers; roller chains;
sprockets and bushings; clutches and torque limiters; timing and
drive belts or pulleys; linear, rotational, plain, ball, tapered,
needle, thrust or mounted bearings; lead screws; ball screws;
linear motion; track or drive rollers; screw jacks; turntables;
shaft collars or couplings; universal joints; rod ends and
linkages; devises; control cables; gas springs; shock absorbers;
encoders; pistons; etc. Additional known mechanisms will be
apparent to those of skill in the art.
[0178] Although a number of illustrative variations are described
above, it will be apparent to those skilled in the art that various
changes and modifications may be made thereto without departing
from the scope of the invention. Moreover, although specific
configurations and applications may be shown, it is intended that
the various features may be utilized in various types of procedures
in various combinations as practicable. It is intended in the
appended claims to cover all such changes and modifications that
fall within the true spirit and scope of the invention.
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